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临床试验/NCT01586377
NCT01586377已完成不适用

Near-infrared Spectroscopic Measurement of Tissue Oxygen Saturation and the Vascular Occlusion Test in Complex Regional Pain Syndrome

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Baseline tissue oxygen saturation

研究概览

简要总结

Recent clinical investigations have suggested that the cause of abnormal pain in complex regional pain syndrome could be ischemia and inflammation, due to poor blood flow to deep tissues from microvascular pathology. This study aims to determine if a new technology called near infrared spectroscopy can measure this microvascular dysfunction. The study hypothesizes that significant differences can be measured in the microcirculation of patients with CRPS-I using near infrared spectroscopy and the vascular occlusion test.

详细描述

The pathophysiology of CRPS-1 is unknown yet a considerable number of studies suggest that the fundamental cause of abnormal pain is due to microvascular pathology of deep tissues.

Reduced blood flow to deep tissues such as muscle, nerve, and bone can lead to a combination of inflammatory and neuropathic pain processes (Coderre TJ et al. 2010). Evidence to support this model of microcirculatory dysfunction includes observations that skin capillary oxygenation is decreased and skin lactate is increased in affected limbs of patients (total of 11 patients in lactate study) (Birklein F et al. 2000, Manahan AP et al. 2007). It has also been reported that patients with CRPS-I have abnormal vasodilatory responses after sympathetically-mediated vasoconstriction (Dayan L et al. 2008) and decreased concentrations of nitric oxide in the affected limb (Groeneweg JG et al. 2006).

Near-infrared spectroscopy (NIRS) is a non-invasive method of measuring tissue oxygenation using the differential absorption properties of oxygenated and deoxygenated hemoglobin in biological tissue (Creteur J 2008). Near-infrared light is only transmitted through small vessels with diameter less than 1 mm (arterioles, venules and capillaries). Since NIRS is limited to monitoring only small vessels, it can be used to assess oxygen balance in the microcirculation of skeletal muscle (Creteur J 2008).

Premises Premise 1: Complex regional pain syndrome is associated with microcirculatory dysfunction

After an injury to a patient's limb, it is hypothesized that the pressure exerted by that swelling within a relatively confined anatomical space can occlude the capillaries of adjacent tissues and cause a compartment syndrome-like injury. Coderre et al. (2010) have theorized that the resulting microcirculatory dysfunction causes a persistent inflammatory state which is then responsible for pain generation.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Complex regional pain syndrome type 1 (CRPS-I) of one upper extremity.
  • Healthy volunteers.
  • Diagnosis of CRPS-I established for greater than 12 weeks.

排除标准

  • Pregnancy
  • Lack of informed consent
  • History of peripheral vascular disease requiring angioplasty or bypass surgery
  • History of systemic vasculitis
  • Current use of vasoactive medications
  • Diabetes Type I and II
  • Presently smoking

结局指标

主要结局

Baseline tissue oxygen saturation

时间窗: Day 1

次要结局

  • Occlusion slope during vascular occlusion test(Day 1)
  • Reperfusion slope during vascular occlusion test(Day 1)
  • Delta StO2(Day 1)
  • Post-obstructive hyperemic response(Day 1)
  • Thenar muscle oxygen consumption(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Geoff Bellingham

Principal Investigator

Lawson Health Research Institute

研究点 (1)

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